Senators
were taken off guard by the public outrage over the passing of bill S.1082
with language that can be used to seriously harass dietary supplements
by enabling the FDA to apply drug-related risk analysis to the safety
of food and food ingredients (and thus dietary supplements). Senators
are also struggling to defend the fact they enabled the creation of the
Reagan-Udall Foundation for the FDA, having been conned into believing
this foundation was for the purpose of improved safety when in fact its
mission is to assist the FDA to develop the next generation of drugs with
drastically reduced safety or effectiveness testing. These issues are
fully explained in Part
1 of this article, if you would like to know the details in greater
depth.

This
week the Senate has unleashed a damage control campaign, sending out numerous
e-mails to those who have been complaining over the past few weeks. The
goal of these letters is to calm apprehensions about dietary supplements
and seek to convince everyone that dietary supplements are not in any
danger. I thank those of you who have sent me your Senator�s spin, and
no letter was better than the one I received from my Senator, Norm Coleman
(R-MN). I am taking the liberty of answering his form letter publicly,
as it is reflective of the arguments the Senate is using to confuse and
pacify the American public. The following Coleman statements are extracted
from his e-mail.

Coleman:
I am very concerned with the Food and Drug Administration's (FDA) efficiency
in reviewing prescriptions drugs as well as its track record on appropriate
enforcement.

Richards:
Then why didn�t you vote for the Grassley and Durbin amendments that would
have given some real meaning to drug safety at the FDA? And why didn�t
you or any one of your colleagues raise a single question about the Reagan-Udall
Foundation for the FDA and its desire to help the FDA bring drugs to the
market with far less safety and effectiveness testing?

Coleman:
I understand that concerns have been raised regarding the bill's proposal
for the Reagan-Udall Foundation and dietary supplements. First, I want
to assure you that this bill does not regulate or restrict access to dietary
supplements in any way.

Richards:
It is true that the bill does not directly state that it intends to regulate
or restrict access to dietary supplements. However, language within the
section establishing the Regan-Udall Foundation grants the FDA new regulatory
power to brand food ingredients (and thus dietary supplements) as unsafe
utilizing the Critical Path Initiative drug-related risk assessment technology.

Coleman:
Second, the bill would establish the Reagan-Udall Foundation as a non-government
entity that would have no control over the FDA, industry, or consumers.

Richards:
Excuse me Senator � did you read the bill? The board of directors is composed
of the Commissioner of the FDA, the Director of the National Institutes
of Health, the Director of the Centers for Disease Control and Prevention,
the Director of the Agency for Healthcare Research and Quality, 4 representatives
from Big Pharma and Big Biotech, 3 representatives from academia (which
is funded by Big Pharma), 2 more from the FDA and NIH, 2 from consumers
groups, and 1 from health care providers. This means that the FDA/Big
Pharma/Big Biotech voting block always has 13 votes � to at the most 3.
Who are you kidding? This front group foundation is run by the FDA in
combination with the industry it is supposed to be regulating. This makes
the FDA part of the drug business as a drug company.

Coleman:
Furthermore, the Foundation will not be involved in drug development but
will help provide new tools for improving safety in regulated product
development.

Richards:
Now I�m sure you didn�t read the bill. It says the Foundation will ensure
that �action is taken as necessary to enable the licensing of inventions
developed by the Foundation or with funds from the Foundation; and (C)
executed licenses, memoranda of understanding, material transfer agreements,
contracts, and other such instruments, promote, to the maximum extent
practicable, the broadest conversion to commercial and noncommercial applications
of licensed and patented inventions of the Foundation.� Since the Foundation
is responding to the needs of the Critical Path Initiative, and that initiative
is primarily about the development of new drugs, it is clear that the
Foundation will not only help with drug development but it will have significant
business relationships as a result. Are you not aware of the fact that
non-profits are the new vehicle by which multi-national corporations shelter
their inventions from international competition?

Coleman:
I have also heard concerns with provisions in the mission of the Foundation
related to food and food ingredients. This has to do with food safety,
and not with dietary supplements. As the recent disease outbreaks associated
with spinach and peanut butter have shown, food safety tools are lacking.
The Foundation would undertake research to help make food safer but it
would have no regulatory authority.

Richards:
Americans do not trust the FDA. By law, dietary supplements are food and
food ingredients. I am all in favor of the FDA being better able to identify
contamination in food that poses a risk to human health. At least we agree
on that point. The point we don�t agree on is the fact the technology
in question relies on drug risk analysis and can be used to claim that
a nutrient that is not in any way contaminated is unsafe, thus undermining
the very foundation of food and drug law. The Foundation is being positioned
as a major tool for the FDA to implement its opinionated use of this technology,
which can easily be used to attack dietary supplements.

Since
you and every other Senator that has been questioned on this issue would
like to deny there is any problem with this legislation regarding dietary
supplements, why don�t you help put some language into this legislation
that will satisfy all of our concerns. After all, what harm is there in
taking some action to SHOW THE PEOPLE that you truly are not interested
in allowing the FDA to have new power to harass dietary supplements and
suppress freedom of choice relating to health care options.

The
following simple amendment has been prepared by noted attorney, Jonathan
Emord.

Purpose
of Amendment

The
purpose of the amendment is to ensure that foods, dietary ingredients,
and dietary supplements are not treated like drugs when evaluated by the
Food and Drug Administration. Since the turn of the Twentieth Century,
the Supreme Court and most of the lower federal courts have accepted the
principle first articulated by Paracelsus in the 16th Century that dose
determines toxicity. That bedrock principle underlies all of adulteration
law. The FDA has unilaterally removed that principle from the law of adulteration
as it pertains to dietary ingredients and dietary supplements. In its
place, FDA has required dietary ingredients and dietary supplements to
be treated like drugs when evaluating whether they are adulterated. In
particular, FDA for the first time in its history now holds a dietary
ingredient or dietary supplement adulterated at every dose level if at
some dose level it can be shown to present even an infinitesimal risk
if it concludes there to be no substantial health benefit from the supplement.

Because
all dietary ingredients, dietary supplements, and foods present a risk
to health at some level of ingestion, the FDA�s new position permits the
agency to declare any dietary ingredient or dietary supplement adulterated
at its whim or caprice. The drug risk-benefit comparison was until recently
reserved exclusively for drugs because under the FDCA foods, food ingredients,
and dietary supplements are presumed safe in light of their ubiquitous
presence in the food supply and history of safe ingestion. Consistent
with the plain and intended meaning of the Dietary Supplement Health and
Education Act, a dietary supplement is not adulterated unless FDA proves
by a preponderance of the evidence that the supplement presents a significant
or unreasonable risk of illness or injury under conditions of use recommended
or suggested in labeling, or if no conditions of use are recommended or
suggested in labeling, under ordinary conditions of use. FDA�s imposition
of a drug standard risk-benefit comparison on dietary supplements is not
sanctioned by the Act and exceeds the statutory limits on FDA�s power.
That imposition violates the plain and intended meaning of the dietary
supplement adulteration provision adopted by the Congress in the DSHEA.
This amendment ends that violation by removing the term �unreasonable�
as a modifier of risk, making it clear that the focus of the statute is
on significant risk, not on a comparison of risk with benefit.

To ensure
that the Foundation or Institute created by the bill does not undermine
Congress�s plain and intended meaning, this amendment also prohibits that
entity from evaluating the health benefit or efficacy of foods, dietary
ingredients, and dietary supplements by limiting its review to determining
whether those ingredients or supplements present a significant risk of
illness or injury under conditions of use recommended or suggested in
labeling, or if no conditions of use are recommended or suggested in labeling,
under ordinary conditions of use.

The
following provides a print of the existing statute or part or section
thereof to be amended or replaced (existing law proposed to be omitted
is enclosed in black brackets, new matter is printed in italic, existing
law in which no change is proposed is shown in roman):

CHAPTER
IV � FOOD

SEC.
402

(f)
�

(1) If it is a
dietary supplement or contains a dietary ingredient that �
(A) presents a significant [or unreasonable] risk of illness or injury
under�

(i) conditions
of use recommended or suggested in labeling, or
(ii) if no conditions of use are suggested or recommended in the labeling,
under ordinary conditions of use:

Changes
in Proposed Bills

Proposed
amendment to S 1082 and HR 1561:

The
bills are hereby amended to prohibit the Foundation or Institute from
evaluating the health benefit or efficacy of foods, dietary ingredients,
and dietary supplements and to limit review of foods, dietary ingredients
and dietary supplements to a determination of whether they are safe. In
assessing whether dietary ingredients and dietary supplements are safe,
the Foundation or Institute shall not compare product risks with health
benefits or efficacy. Instead, the Foundation or Institute shall determine
whether the product presents a significant risk of illness or injury under
conditions of use recommended or suggested in labeling, or if no conditions
of use are recommended or suggested in labeling, under ordinary conditions
of use.

Health
Freedom is on the Line

It is
vitally important to send the following message to all members of the
House and keep flooding the Senate (as there will be a conference committee).
It is also important to send this message to Senators Hatch and Harkin
(the original designers of DHSEA) and Kennedy and Enzi (who claim they
are not trying to regulate dietary supplements with this legislation).
These Senators must hear from the American public as they will determine
the fate of this amendment when it reaches the conference committee. Success
will require significant support from the people. Thank you.

The
Senate has recently passed bill S1082, commonly known as the FDA Revitalization
Act. I am concerned that the legislation, as currently written, opens
the door for considerable regulatory confusion enabling the FDA to use
this legislation to undermine my access to safe and effective dietary
supplements.

There
must be no confusing the safety of drugs and the safety of food and food
ingredients � which are governed by different laws. I am sure you and
other members of Congress are not intending to create such concern among
the 150 million Americans who rely on dietary supplements to assist their
health, and this matter is easily corrected with the following amendment,
which will not in any way stop the FDA from identifying truly contaminated
food that poses a risk to human health.

Changes
in Existing Law

The
following provides a print of the existing statute or part or section
thereof to be amended or replaced (existing law proposed to be omitted
is enclosed in black brackets, existing law in which no change is proposed
is shown in roman):

CHAPTER
IV � FOOD

SEC.
402(f) �

(1) If it is a
dietary supplement or contains a dietary ingredient that �
(A) presents a significant [or unreasonable] risk of illness or injury
under�

(i) conditions
of use recommended or suggested in labeling, or
(ii) if no conditions of use are suggested or recommended in the

labeling,
under ordinary conditions of use:

Changes
in Proposed Bills

Proposed
amendment to S 1082 and HR 1561:

The
bills are hereby amended to prohibit the Foundation or Institute from
evaluating the health benefit or efficacy of foods, dietary ingredients,
and dietary supplements and to limit review of foods, dietary ingredients
and dietary supplements to a determination of whether they are safe. In
assessing whether dietary ingredients and dietary supplements are safe,
the Foundation or Institute shall not compare product risks with health
benefits or efficacy. Instead, the Foundation or Institute shall determine
whether the product presents a significant risk of illness or injury under
conditions of use recommended or suggested in labeling, or if no conditions
of use are recommended or suggested in labeling, under ordinary conditions
of use. Please help preserve my rights and support this amendment. For
part 1 click below.

Richards encourages
individuals to take charge of their health, stand up for their health
rights, and not blindly succumb to propaganda from the vested-interests
who profit from keeping Americans sick. As founder of Wellness Resources,
Inc. of Minneapolis, MN, an independently-owned fine-quality dietary supplement
company since 1985, he has personally developed 75 unique nutraceutical-grade
nutritional formulas. www.wellnessresources.com

Senators
were taken off guard by the public outrage over the passing of bill S.1082
with language that can be used to seriously harass dietary supplements
by enabling the FDA to apply drug-related risk analysis to the safety
of food and food ingredients...